This trial is active, not recruiting.

Summary

A new Male Circumcision (MC) device, PrePex, has shown great promise as a way to radically
shift the MC landscape. PrePex is an innovative circumcision device requiring no injected
anesthesia, sutures, or sterile settings. Moreover, it is designed for use by minimally
skilled healthcare professionals rather than surgeons. Two initial studies conducted in
Rwanda in 2010 and 2011 demonstrated an excellent safety profile when the procedure was
performed by skilled physicians

Study Design

Male circumcision using the PrePex device among healthy adolescent males and contraindicated subjects due to Preputial adhesions and /or narrow foreskin/Phimosis

prepex device

The PrePex device is designed to enable conducting male circumcision procedure that is bloodless with no anesthesia and no sutures. For contraindicated subjects, a preparation procedure will take place.

Primary Outcomes

Measure

Incidence of Serious Adverse Events on adolescent male population including contraindicated subjects in ages 10 to 17

time frame:
up to 7 weeks

Secondary Outcomes

Measure

Glans fully exposed

time frame:
Up to 7 weeks

The pain at key time points

time frame:
Up to 7 weeks

Time to complete healing

time frame:
Up to 7 weeks

Time to numb the foreskin using topical Lidocaine 5% cream - for contraindicated subjects only

time frame:
Up to 7 weeks

Rate of side effects

time frame:
Up to 7 weeks

Eligibility Criteria

Male participants from 10 years up to 17 years old.

Inclusion Criteria:
- Adolescent Males in ages - 10 to 17 years
- Uncircumcised
- Subject wants to be circumcised
- Subject assent to the procedure
- Legal guardian consent to the procedure
- Subject with or without the following conditions: Preputial adhesions and /or narrow
foreskin/Phimosis
- Able to understand the study procedures and requirements
- Agrees to abstain from sexual intercourse for 8 weeks after circumcision
- Agrees to abstain from masturbation for at least 2 weeks after Removal
- Agrees to return to the health care facility for follow-up visits (or as instructed)
after his circumcision for a period of 7 weeks post removal (8 weeks total)
- Subject able to comprehend and freely give informed consent for participation in this
study and is considered by the investigator to have good compliance for the study
- Subject agrees to anonymous video and photographs of the procedure and follow up
visits.
Exclusion Criteria:
- Legal guardian withholds consent
- Active genital infection, anatomic abnormality or other condition, which in the
opinion of the investigator prevents the subject from undergoing a circumcision
- Subject with the following diseases/conditions: paraphimosis, warts under the
prepuce, torn or tight frenulum, hypospadias, epispadias
- Known bleeding / coagulation abnormality, uncontrolled diabetes
- Subject that to the opinion of the investigator is not a good candidate
- Subject does not agree to anonymous video and photographs of the procedure and follow
up visits.

Additional Information

Official title

A Safety and Efficacy Study of Non-surgical MC Device on PrePex Adolescent Male Population, Including Contraindicated Subjects Scheduled to Undergo Circumcision in an Effort to Prevent the Spread of HIV in Resource Limited Settings

Principal investigator

Vincent Mutabazi, M.D.

Description

Rwanda Has also completed a third study to assess the safety and efficacy of MC when
performed by nurses using PrePex in both rural and urban hospitals, Device safety was
assessed by the rate of clinical adverse events and device-related incidents attributed to
the PrePex device and its procedures, the study report was shared with the WHO Male
Circumcision Technical Advisory Group. On February 2011 the WHO provided Rwanda with
recommendation to phase in MC scale up with the PrePex device on adults. Moreover the WHO
recommended Rwanda to study the PrePex for use on adolescent population, starting on ages
15-17 and thereafter on ages 12-14 and 10-12.

Trial information was received from ClinicalTrials.gov and was last updated in October 2015.

Information provided to ClinicalTrials.gov by Ministry of Health, Rwanda.